Moderate to Severe Crohn's DiseasePhase 1/2NCT00630643
NI-0401 in Active Crohn's Disease
A Phase 1/2 study testing NI-0401 (anti-CD3 mAB) in people with Moderate to Severe Crohn's Disease, run by Light Chain Bioscience - Novimmune SA.
Trial summary
The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate to Severe Crohn's Disease
- What is being tested?
- NI-0401 (anti-CD3 mAB)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Men and women between 18 and 70 years of age.
- Crohn's Disease Activity Index (CDAI) between 220 and 450.
- Raised plasma CRP level.
- Endoscopic inflammation.
- Crohn's disease of at least 6 months duration, with colitis, ileitis, or ileocolitis, confirmed by endoscopy and histology within 28 days of study day 1.
Main Exclusion criteria
- Have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation.
- Concomitant disease:
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis)
- Previous diagnosis of, or known, malignancies
- Severe infections, such as hepatitis, pneumonia or pyelonephritis, in the past three months. Less serious infections in the past 3 months, such as acute upper respiratory tract infection (colds) or uncompliant urinary tract infection are permitted at the discretion of the investigator
- Active infection requiring antibiotic therapy
- Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive
- History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of acute CMV or EBV, active Pneumocystic Carinii
- History of active tuberculosis (TB) or currently undergoing treatment for TB. Patients with a positive TB skin test or chest x-ray are ineligible. Patients with a history of bacille Calmette Guerin (BCG) vaccination and a newly positive TB skin test or a chest X-ray showing fibrotic lesions consistent with previous TB are ineligible. The PPD skin test must be read between 48 and 72 hours
- Stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium Difficile toxin within 4 weeks prior to Study Day 1
About this study
Official title: A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease
The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells.
- Conditions
- Moderate to Severe Crohn's Disease
- Being tested
- NI-0401 (anti-CD3 mAB), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NI-0401 (anti-CD3 mAB)Biological
0.05 mg up to 10 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Biological: NI-0401 (anti-CD3 mAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of intravenous NI-0401 .
Measured: 24 weeks
Secondary outcomes (1)
Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Light Chain Bioscience - Novimmune SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janeeke Van der Woude, MD, Principal investigator, Erasmus Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630643
- Sponsor's protocol ID
- NI-0401-01
- Status last verified
- Feb 2008
- First submitted
- 28 Feb 2008
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease
- ClinicalTrials.gov ID
- NCT00630643
- Acronym / sponsor ID
- NI-0401-01
- Conditions
- Moderate to Severe Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Light Chain Bioscience - Novimmune SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Biological: NI-0401 (anti-CD3 mAB) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NI-0401 (anti-CD3 mAB)0.05 mg up to 10 mg | Biological | 2 |
| PlaceboPlacebo | Drug | 1 |
Primary outcome
Safety and tolerability of intravenous NI-0401 .
Time frame: 24 weeks
1 secondary outcome
Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janeeke Van der Woude, MD principal investigator
Erasmus Medisch Centrum
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NI-0401 (anti-CD3 mAB) in people with Moderate to Severe Crohn's Disease, run by Light Chain Bioscience - Novimmune SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of intravenous NI-0401 . (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2008.